2024-04590. Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories; Correction

AGENCY:

Centers for Medicare & Medicaid Services (CMS) and Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

ACTION:

Final rule; correction.

SUMMARY:

This document corrects technical and typographical errors in the final rule that appeared in the December 28, 2023, Federal Register entitled, “Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories” (referred to hereafter as the “December 2023 final rule”).

DATES:

This correction is effective March 5, 2024, and is applicable beginning January 27, 2024.

FOR FURTHER INFORMATION CONTACT:

Penny Keller, CMS, (410) 786–2035; or Heather Stang, CDC, (404) 498–2769.

SUPPLEMENTARY INFORMATION:

I. Background

In FR Doc. 2023–28170 of December 28, 2023, the December 2023 final rule (88 FR 89976), there were technical and typographical errors that are identified and corrected in this correcting document. These corrections are applicable beginning January 27, 2024, as if they had been included in the December 2023 final rule.

II. Summary of Errors

On page 89985, in the first footnote to the table titled, “TABLE 4: Examples, Two-part Increase per Certificate Type”, we inadvertently included incorrect amounts for the current and updated Certificate of Registration (CoR) fees. As stated in the proposed rule that appeared in the July 26, 2022, Federal Register entitled, “Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories”, the correct current CoR fee was $100. With application of the one-time across-the-board (ATB) increase of 18 percent along with the biennial two-part fee increase of 4.9598 percent, the correct updated fee amount is $123.

Similarly on page 90027, in the table titled, “TABLE 17: Two-part Biennial Certificate Fee”, in the Certificate of Registration (CoR) row, we inadvertently included incorrect amounts in the “Current fee” and “New average fee” columns. We are correcting as described previously.

On page 90028, in the table titled, “TABLE 18: CLIA Replacement and Revised Certificates FY 2019”, we made typographical errors in the “Cost of Revised Certificate” entries for the Certificate of Accreditation (CoA) and Certificate for Provider-performed Microscopy (PPM) certificate types. The amounts were reversed in the table. The corrected certificate fees for each of these revised certificate types corresponds to the fees in Table 6, “CMS Proposed Fee for Issuance of Revised Certificate” in the final rule.

III. Waiver of Proposed Rulemaking and Delay in Effective Date

Under 5 U.S.C. 553(b) of the Administrative Procedure Act (APA), the agency is required to publish a notice of the proposed rulemaking in the Federal Register before the provisions of a rule take effect. Section 553(d) of the APA ordinarily requires a 30-day delay in effective date of final rules after the date of their publication in the Federal Register .

Section 553(b)(B) of the APA authorizes an agency to dispense with normal rulemaking requirements for good cause if the agency makes a finding that the notice and comment process is impracticable, unnecessary, or contrary to the public interest. In addition, section 553(d)(3) of the APA allows the agency to avoid the 30-day delay in effective date where such delay is contrary to the public interest and an agency includes a statement of support.

We believe this correcting document does not constitute a rule that would be subject to the notice and comment or delayed effective date requirements. This document merely corrects technical and typographical errors in the December 2023 final rule but does not make substantive changes to the policies that were adopted in the December 2023 final rule. Instead, this correcting document is intended to ensure that the information in the December 2023 final rule accurately reflects the policies adopted in that document.

In addition, even if this were a rule to which the notice and comment procedures and delayed effective date requirements applied, we find that there is good cause to waive such requirements. Undertaking further notice and comment procedures to incorporate the corrections in this document into the December 2023 final rule or delaying the effective date would be contrary to the public interest because it is in the public's interest to ensure that the December 2023 final rule accurately reflects the policies finalized in that final rule. Furthermore, such procedures would be unnecessary, as we are not altering our policies, but rather, we are simply correctly implementing the policies we finalized. This final rule correction is intended to ensure that the December 2023 final rule accurately reflects those policies. Therefore, we believe we have good cause to waive the notice and comment and delayed effective date requirements.

IV. Correction of Errors

In FR Doc. 2023–28170 of Thursday, December 28, 2023 (88 FR 89976), the following corrections are made:

1. On page 89985, in the first footnote to the table titled, “TABLE 4: Examples, Two-part Increase per Certificate Type”, the language that reads, “Note: The Certificate of Registration (CoR) fee would increase from the $150 to $184.” is corrected to read, “Note: The Certificate of Registration (CoR) fee would increase from the $100 to $123.”

2. On page 90027, in the table titled, “TABLE 17: Two-part Biennial Certificate Fee”, the last row that reads:

Table 17—Two-Part Biennial Certificate Fee

Type of CLIA Certificate	Laboratory schedule	Current fee (c)	New average (n) ATB and biennial increase = 18% * 4.96%	Number of laboratories *	Number of laboratories divided by 2 **
Certificate of Registration (CoR)	Not applicable	$150	$184	2891	1,445.5

is corrected to read:

Table 17—Two-Part Biennial Certificate Fee

Type of CLIA Certificate	Laboratory schedule	Current fee (c)	New average (n) ATB and biennial increase = 18% * 4.96%	Number of laboratories *	Number of laboratories divided by 2 **
Certificate of Registration (CoR)	Not applicable	$100	$123	2891	1,445.5

3. On page 90028, in the table titled, “TABLE 18: CLIA Replacement and Revised Certificates FY 2019”, rows 4 and 5 that read:

Table 18—CLIA Replacement and Revised Certificates FY2019 *

Certificate type	Number of replacement certificates issued in FY2019	Cost of replacement certificate	Number of revised certificates issued in FY2019	Cost of revised certificate
CoA	496	$75	505	$150
PPM	525	75	984	95

are corrected to read:

Table 18—CLIA Replacement and Revised Certificates FY2019 *

Certificate type	Number of replacement certificates issued in FY2019	Cost of replacement certificate	Number of revised certificates issued in FY2019	Cost of revised certificate
CoA	496	$75	505	$95
PPM	525	75	984	150

Elizabeth J. Gramling,

Executive Secretary to the Department, Department of Health and Human Services.